Impact of a Hospital Pharmacist's Intervention on FENO (Fractional Exhaled Nitric Oxide) in Asthmatic Patients

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Questionnaires for control group; Other: Pharmacist's intervention

• Registration Number: NCT03093363
• Lead Sponsor: University of Liege

Brief Summary

The impact of a pharmacist's intervention on asthma control has now been well demonstrated, but its effect on inflammatory markers of FENO (Fractional exhaled nitric oxide) in asthmatic patients has been little studied in the literature. The aim of this study is to investigate the impact of a pharmacist's intervention on FENO in patients seen in clinical practice by a pneumologist in a secondary university center.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-31
• Study First Submitted: 2017-03-11
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-28
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Adult asthmatics (definition of asthma: FEV1 [forced expiratory volume in 1 second] reversibility of at least 12% and 200 mL after 400 mcg of salbutamol and/or PC20M [provocative concentration of methacholine causing a 20% fall in FEV1]<16 mg/mL)
• unchanged or increased dose of inhaled corticosteroids prescribed by the pneumologist at the visit
• FENO (fractional exhaled nitric oxide) > or = 25 ppb

Exclusion Criteria

• Treatment with oral corticosteroids to treat an asthma exacerbation within 4 weeks before the visit with the pneumologist

Exclusion Criteria during the study:

• Change of the dose of ICS (inhaled corticosteroids) during the follow-up of 3 months after the pharmacist's intervention
• Severe asthma exacerbation requiring oral corticosteroids within the 4 weeks before the follow-up visit (3 months after the pharmacist's intervention)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Questionnaires for control group	Asthmatic patients without the pharmacist's intervention (only questionnaires)
Intervention group	Pharmacist's intervention	Asthmatic patients with the pharmacist's intervention

Primary Outcome Measures

Name	Time	Method
Change from Baseline FENO (fractional exhaled nitric oxide) at 3 months	3 months	Fractional exhaled nitric oxide

Secondary Outcome Measures

Name	Time	Method
Change from Baseline smoking status at 3 months	3 months	Smoking status is recorded as non-smoker, ex-smoker, current smoker
Change from Baseline FEV1 (forced expiratory volume in 1 second) at 3 months	3 months
Change from Baseline FVC (forced vital capacity) at 3 months	3 months
Change from Baseline FEV1/FVC at 3 months	3 months
Change from Baseline ACQ (Asthma Control Questionnaire) at 3 months	3 months
Change from Baseline ACT (Asthma Control Test) at 3 months	3 months
Change from Baseline miniAQLQ (Asthma Quality of Life Questionnaire) at 3 months	3 months
Change from Baseline MARS (Medication Adherence Report Scale) at 3 months	3 months	Measure of treatment adherence
Change from Baseline MRA (Medication Refill Adherence) at 3 months	3 months	Measure of treatment adherence
Change from Baseline score of the inhalation technique at 3 months	3 months
Change from Baseline number of severe exacerbations (during the 3 previous months) at 3 months	3 months	Severe exacerbations are asthma exacerbations requiring oral corticosteroids
Satisfaction of patients with the pharmacist's intervention, with a scale from 0 to 10	3 months after intervention
Changes in lifestyle related to asthma (free text field to complete by the patient)	3 months after intervention